Listing of Upcoming Meetings from FDA Live - 4/30/2012

FDALive is the World's Leading Source for FDA Broadcasting. Below is the list of upcoming meetings, current as of April 30, 2012:

Pediatric AdComm

Meeting Date: 5/7/12-5/8/12  

Agenda: On May 7, 2012, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Differin Lotion (adapalene), Dulera Inhalation Aerosol (mometasone furoate and formot...

 

Arthritis AdComm

Meeting Date: 5/8/12-5/8/12  

The committee will discuss supplemental biologics license application 125249, ARCALYST (rilonacept) injection, Regeneron Pharmaceuticals, Inc., for the following proposed indication: "ARCALYST (rilonacept) is an interleukin-1 blocker indicated for the prevention of gout flares during initiation o...

 

Arthritis AdComm

Meeting Date: 5/9/12-5/9/12  

The committee will discuss new drug application (NDA) 203214, tofacitinib tablets, Pfizer Inc., for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs....

Antiviral Drugs AdComm

Meeting Date: 5/10/12-5/10/12  

The committee will discuss an efficacy supplement for new drug application (NDA) 21-572, TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet, submitted by Gilead Sciences, Inc. The supplemental application proposes an indication for Pre-Exposure Prophylaxis (PrEP) to reduce the risk...

Endocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/10/12-5/10/12  

The committee will discuss the safety and efficacy of new drug application (NDA) 22–529 (lorcaserin hydrochloride) tablets, manufactured by Arena Pharmaceuticals, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than ...

 

Gastroenterology and Urology Devices Panel of the Medical Devices AdComm

Meeting Date: 5/10/12-5/11/12  

On May 10 and 11, 2012, the committee will discuss general issues related to medical devices intended for obese patients. The committee will provide recommendations regarding trial design for clinical studies to evaluate the safety and effectiveness of weight loss devices placed either endoscopic...

 

Antiviral Drugs AdComm

Meeting Date: 5/11/12-5/11/12  

The committee will discuss new drug application (NDA) 203-100, for a fixeddose combination tablet of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, submitted by Gilead Sciences, Inc. The application proposes an indication for the treatment of HIV-1 infection in adults who ar...

Cardiovascular and Renal Drugs AdComm

Meeting Date: 5/23/12-5/23/12  

On May 23, 2012, the Committee will discuss supplemental new drug application (sNDA) 202439/S-002 XARELTO (rivaroxaban), submitted by Janssen Pharmaceuticals, Inc. to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) [ST elevation myocardial infarctio...

 

Peripheral and Central Nervous System Drugs AdComm

Meeting Date: 5/24/12-5/24/12  

On May 24, 2012, the committee will discuss new drug application (NDA) 202737 for tafamidis meglumine capsules, proposed trade name VYNDAQEL, submitted by FoldRx Pharmaceuticals, Inc. a subsidiary of Pfizer, Inc. The proposed indication is for the treatment of transthyretin (TTR) familial amyloid po...

Circulatory System Devices Panel of the Medical Devices AdComm

Meeting Date: 5/24/12-5/24/12  

On May 24, 2012, the committee will discuss current knowledge about the safety and effectiveness of the AMPLATZER ASO Device & Gore HELEX ASD Occluder as transcatheter Atrial Septal Defect (ASD) occluders used for the closure of secundum atrial septal defects. The AMPLATZER Septal Occluder (ASO) ...

 

Assessment of Analgesic Treatment of Chronic Pain--A Public Workshop

Meeting Date: 5/30/12-5/31/12  

The purpose of the meeting is to provide a forum to discuss the available data on the use of analgesics in the treatment of CNCP, beginning with a discussion of the underlying mechanisms of chronic pain and the epidemiology of chronic pain in the United States. Next, data on the efficacy of opioi...

 

Gastrointestinal Drugs AdComm

Meeting Date: 5/31/12-5/31/12  

The committee will discuss new drug application (NDA) 200-436, synthetic human secretin, sponsored by Repligen Corporation, proposed for use with magnetic resonance imaging (MRI) to improve pancreatic duct visualization for the detection of duct abnormalities to enhance clinical decision making i...

 

Circulatory System Devices Panel of the Medical Devices AdComm

Meeting Date: 6/13/12-6/13/12  

On June 13, 2012, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIEN Transcatheter Heart Valve is indicated for use in patient...

Oncologic Drugs AdComm

Meeting Date: 6/20/12-6/20/12  

On June 20, 2012, during the morning session, the committee will discuss new drug application (NDA) 203213, with the established name semuloparin sodium injection, application submitted by sanofi-aventis U.S. LLC. The proposed indication (use) for this product is for the prophylaxis of venous thr...

General and Plastic Surgery Devices Panel of the Medical Devices AdComm

Meeting Date: 6/21/12-6/21/12  

On June 21, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Dune Medical Devices, Inc., for the MarginProbe System, that utilizes electromagnetic waves to characterize human tissue in real time and provide...

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